Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

NCT01519596 | Completed

• 3 other identifiers: IRB00019467NCI-2012-00003CCCWFU 97711
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.

Conditions

Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Feasibility, in terms of participation rates and barriers to recruitment and retention

  Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.

  Approximately 4 weeks

• Magnitude and trajectory of changes in objective physical function

  Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.

  Approximately 4 weeks

Secondary Outcomes (2)

• Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength

  Approximately 4 weeks

• Self-reported quality of life

  Approximately 24 weeks

Study Arms (2)

Arm I (physical activity)

EXPERIMENTAL

Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.

Procedure: quality-of-life assessment; Other: counseling intervention; Behavioral: exercise intervention; Other: educational intervention

Arm II (usual care)

ACTIVE COMPARATOR

Patients undergo usual care for 4 weeks.

Procedure: quality-of-life assessment; Procedure: standard follow-up care

Interventions

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (physical activity); Arm II (usual care)

counseling intervention OTHER

Receive lifestyle-related counseling

Also known as: counseling and communications studies

Arm I (physical activity)

exercise intervention BEHAVIORAL

Undergo physical activity intervention

Arm I (physical activity)

educational intervention OTHER

Receive educational materials

Also known as: intervention, educational

Arm I (physical activity)

standard follow-up care PROCEDURE

Undergo usual care

Arm II (usual care)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria
• Planned induction chemotherapy
• Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)
• Patient must be ambulatory or able to walk with a cane
• Patients must have limited cognitive deficits (\< 3 incorrect responses on the Pfeiffer Mental Status Scale)
• Adequate English skills to understand and complete questionnaires
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
• Inability to ambulate

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Klepin HD, Tooze JA, Rejeski WJ, Mihalko S, Pardee TS, Ellis L, Howard D, Demark-Wahnefried W, Powell BL, Kritchevsky S. Pilot study of an inpatient physical activity intervention for older adults treated intensively for acute myeloid leukemia. Blood Adv. 2025 Oct 28;9(20):5152-5163. doi: 10.1182/bloodadvances.2025016260.

  PMID: 40737540 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities; Leukemia, Myeloid, Acute

Interventions

Counseling; Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Investigative Techniques

Study Officials

• Heidi Klepin

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 27, 2012
• Study Start: October 1, 2012
• Primary Completion: March 5, 2015
• Study Completion: February 5, 2017
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

US (1)